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FDA 510(k)

Nasal Pancreatic Drainage Set

K-Number: K171623 · 2017-07-31

Decision Date2017-07-31
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nasal Pancreatic Drainage Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171623. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nasal Pancreatic Drainage Set?

Nasal Pancreatic Drainage Set is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K171623.

When did Nasal Pancreatic Drainage Set receive FDA 510(k) clearance?

Nasal Pancreatic Drainage Set received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171623.

Who is the listed applicant for Nasal Pancreatic Drainage Set?

The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nasal Pancreatic Drainage Set?

The FDA product code for Nasal Pancreatic Drainage Set is FGE.

Other records listing Cook Ireland, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.